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Study aim:
Determining the effect of acupressure on sleep quality and fatigue in individuals with diabetic neuropathy
Design:
This clinical trial is randomized, double-blind, and controlled, involving 66 patients. Participants are randomly assigned to the intervention and control groups using a coin toss method.
Settings and conduct:
The study is conducted at Khomein health centers with diabetic neuropathy patients. Patients are randomly assigned to intervention (home-based acupressure) and control groups. The study is double-blind, and neither the participants nor the statistical analyst are aware of the group assignments.
Participants/Inclusion and exclusion criteria:
Main Inclusion Criteria
Age between 40 and 79 years، Confirmed type 2 diabetes، HbA1c below 7% (up to 8% for elderly or high hypoglycemia risk patients)، Confirmed peripheral neuropathy.
Main Exclusion Criteria
Unrelated neurological disorders; foot wounds; pregnancy or breastfeeding; use of drugs affecting sleep or fatigue; lower limb injury or surgery; stimulant or alcohol use; recent similar interventions.
Intervention groups:
In the intervention group, acupressure is applied at home for four weeks, three sessions per week, each lasting 26 minutes, focusing on specific points chosen to reduce fatigue and improve sleep quality. Pressure is applied with the thumb at a defined speed and duration. The control group receives a similar acupressure intervention but on sham points to control for placebo effects. All procedures are conducted under trained supervision with standardized conditions maintained during sessions.
Main outcome variables:
Sleep quality؛ fatigue